This invention pertains to a delivery device for the controlled release of active agents to an environment of use. More particularly, the invention pertains to a dual osmotic device for the delivery of active agents over a prolonged and extended period of time. The dual osmotic device comprises a first osmotic device enclosed within a second osmotic device.
Osmotic devices have demonstrated utility in delivering beneficial active agents, such as medicines, nutrients, food, pesticides, herbicides, germicides, algaecides, chemical reagents, and others, to an environment of use in a controlled manner over prolonged periods of time. Known devices include tablets, pills, and capsules.
Advancements in the prior art have focused on developing osmotic devices with improved semipermeable or porous membranes, various coatings surrounding the core and/or the semipermeable membrane, layered osmotically effective agents in the core of the device, specific release profiles for specific active substances, and specific membrane or core compositions.
While the prior art discloses a wide variety of osmotic devices, none of the prior art discloses a dual osmotic device comprising a first osmotic device enclosed within a second osmotic device.
The present invention provides a dual osmotic device, which provides a controlled release device of one or more active agents, comprising a first osmotic device enclosed within a second osmotic device. The first osmotic device provides a controlled release of a first active agent through a passageway in a first semipermeable membrane. The second osmotic device provides a controlled release of a second active agent through a second passageway in a second semipermeable membrane. Both devices deliver their respective active agents through osmotic pumping. In some embodiments, the first and second passageways can be located anywhere on their respective semipermeable membranes.
According to some of the preferred embodiments of the invention, a) one or both of the first and second semipermeable membranes loses its chemical and physical integrity during use; b) the first and second active agents are the same; c) the first and second active agents are different; d) the second semipermeable membrane loses its chemical integrity after about 3-20 hours after administration; e) the second osmotic device delivers a majority of the second active agent by about 3-30 hours after administration; f) the first osmotic device delivers a majority of the first active agent after about 20 minutes after exposure to an aqueous solution; g) the second active agent is delivered to the upper to middle GI tract and first active agent is delivered to the middle to lower GI tract of a mammal to which the dual osmotic device is delivered: h) the first osmotic device provides a controlled delivery of the first active agent, and the second osmotic device provides a controlled delivery of the second active agent; i) the first and second active agents are delivered in one of a concurrent, sequential or overlapping manner; and/or j) the second semipermeable membrane loses its physical integrity within about 3-30 hours after administration.
The invention also provides a therapeutic device for the delivery of pharmaceutically active agents, ranging in solubility from slightly soluble to very soluble drugs, in a controlled, continuous and approximately steady, preferably zero order, rate over a prolonged period of time. Depending upon the excipients used, among other things, the osmotic device can also deliver drugs according to first order, or pseudo-first order release profiles. In addition, the osmotic device may provide targeted delivery of a drug.
The device of the present invention is optionally provided with an external coating disposed on the outside of the second osmotic device and comprising one or more active agents for immediate delivery to the environment of use.
Active agents useful in the delivery device include, for example, compounds such as biologically or pharmacologically active agents, medicines, nutrients, food products, insecticides, pesticides, herbicides, germicides, algaecides, fungicides, chemical reagents, growth regulating substances, parasiticides, sex sterilants, fertility promoters, biocides, rodenticides, disinfectants, anti-oxidants, plant growth promoters, preservatives, fermentation agents, fertility inhibitors, deodorants, micro-organism attenuators, catalysts, food supplements, cosmotics, vitamins, and other agents that benefit the environment of use.
Some specific embodiments of the invention include those wherein the active substance is pharmacologically or biologically active or wherein the environment of use is the GI tract of a mammal.
Other specific embodiments of the device of the invention are used in biological environments including the oral, ocular, nasal, vaginal, glandular, gastrointestinal tract, rectal, cervical, intrauterine, arterial, venous, otic, ophthalmic, sublingual, dermal, epidermal, subdermal, implant, buccal, bioadhesive, mucosal and other similar environments. Likewise, it may be used in aquariums, industrial warehouses, laboratory facilities, hospitals, chemical reactions and other facilities.
Other features, advantages and embodiments of the invention will become apparent to those of ordinary skill in the art by the following description, accompanying examples and appended claims.